Details for New Drug Application (NDA): 065139
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The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 065139
Tradename: | CLINDAMYCIN PHOSPHATE |
Applicant: | Fougera Pharms |
Ingredient: | clindamycin phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065139
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065139
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | CREAM;VAGINAL | 065139 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0277 | 0168-0277-40 | 40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | EQ 2% BASE | ||||
Approval Date: | Dec 27, 2004 | TE: | AB | RLD: | No |
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